WHO Drops Two Generic AIDS Drugs
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Source: http://www.unwire.org/UNWire/20040616/449_24936.asp
Wednesday, June 16, 2004
The World Health Organization has removed two generic antiretro-
viral drugs from its list of approved AIDS drugs used to treat
people in the developing world, the New York Times reports to-
day:
http://www.nytimes.com/2004/06/16/health/16aids.html
The decision was made after a routine check in May found that
the manufacturer, the Indian company Cipla, could not document
that its drugs were biologically equivalent to patented ones.
It is the first time the U.N. health agency has pulled any AIDS
drugs, but the move is not expected to have an effect on its
initiative to treat 3 million HIV-positive people, mostly in Af-
rica, by next year, said WHO official Lembit Rago.
Cipla has been at the forefront of efforts to provide ARVs to
poor nations. Rago said that despite the investigation's find-
ings, the company's drugs, lamivudine and zidovudine, may still
be bioequivalent to the patented drugs. The lack of documenta-
tion, however, required their removal, he said.
Cipla's chairman, Yusuf Hamied, told the Times that the problem
was due to poor recordkeeping in the testing laboratory in Bom-
bay. The company said the situation was "on the mend" and it ex-
pected its drugs back on the list in a matter of weeks.
The announcement follows the Bush administration's decision last
month to allow the purchase of cheaper, generic drugs for Africa
and the Caribbean through its $15 billion, five-year HIV/AIDS
program.
Hamied said lamivudine had been tested for bioequivalency in a
lab in the United States and approved by the Food and Drug Ad-
ministration and that he would send the data to the U.N. agency.
He said the testing had been done for the FDA because his com-
pany hopes to sell lamivudine when a U.S. patent, held by
GlaxoSmithKline of the United Kingdom, expires in 2006
(Altman/McNeil, New York Times, June 16).